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Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547092
First Posted: October 22, 2007
Last Update Posted: October 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
  Purpose
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.

Condition Intervention Phase
Impotence Drug: tadalafil Drug: sildenafil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Preference Assessment measured by the Treatment Preference Question [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary. [ Time Frame: 0, 12, and 26 weeks ]
  • Assess sexual encounters attributes measured by the PAIRS. [ Time Frame: 0, 12, and 26 weeks ]
  • Measure adverse events through the Side Effect Question. [ Time Frame: 12 and 26 weeks ]

Enrollment: 386
Study Start Date: October 2003
Study Completion Date: November 2004
Arms Assigned Interventions
Active Comparator: 1
tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.
Drug: tadalafil
10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 2
sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.
Drug: sildenafil
25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of erection problems
  • Never taken treatments known as PDE5 inhibitors for erection issues
  • Abstain from using any other erection treatments during the study
  • Anticipate a monogamous female sexual relationship
  • Must be able to make required sexual intercourse attempts

Exclusion Criteria:

  • History of other primary sexual disorder
  • Treatment with nitrates
  • Have a penile implant or clinically significant penile deformity
  • History of certain heart problems
  • Do not meet certain lab value reference ranges
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547092


Locations
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Plymouth, United Kingdom
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00547092     History of Changes
Other Study ID Numbers: 7002
H6D-MC-LVFL
First Submitted: October 18, 2007
First Posted: October 22, 2007
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents